Medical Devices Get WHO Spotlight

For the first time, the member States of the WHO South-East Asia Region took up medical devices as a dedicated agenda item at the regional committee meeting at the Dili, Timor-Leste, bringing together medical devices, in vitro diagnostics (IVDs) and assistive technologies under a common life-cycle approach.

The shift is being considered significant by the players in the sector who feel that a medical device is useful only when it is available, appropriate, functional and supported by trained people.

“A diagnostic machine that lies unused because of a missing spare part, a ventilator that is not maintained, or a laboratory test that is unavailable at a primary health centre can be as much a barrier to healthcare as the absence of the technology itself,” said a medical device manufacturer on the WHO SEARO move.

As per the commitment, the countries will move beyond simply purchasing equipment and instead plan for its entire journey — from deciding what is needed and regulating it to procurement, installation, training, maintenance, replacement and safe disposal. The WHO has described this as a move “from purchase to functionality”.

This has a direct bearing on patients, said the experts in the sector. When diagnostic and medical technologies are unavailable or non-functional, diagnosis can be delayed, patients may have to travel or be referred elsewhere, treatment can be postponed and families can end up paying more from their own pockets, said an expert.

As per the WHO, access to safe, effective and affordable medical devices and diagnostics is critical to universal health coverage, particularly at the primary-care level.

The resolution adopted by Member States sets out a series of deadlines. For instance, by 2027, countries are expected to designate a national mechanism or focal unit responsible for the life-cycle management of medical devices and IVDs. The idea is to ensure that responsibility does not remain scattered across procurement, regulation, hospitals and other departments without a clear institutional owner.

By 2028, countries will undertake a national baseline assessment. This will examine where the gaps are in essential diagnostic and medical services, what devices and diagnostics are considered essential, how strong the regulatory system is, and — crucially — where priority equipment is located and whether it is actually functional and maintained.

Further, by 2030, countries are expected to have costed implementation plans linking essential diagnostics and priority medical devices to clinical services, primary healthcare, referral systems, universal health coverage packages, budgets, procurement and workforce requirements.

This could change how governments look at medical equipment. The new approach seeks to measure functionality and access, not merely ownership, experts explained, pointing out that the discussion also comes at a time when medical technology is becoming increasingly complex.

Medical devices now include not only conventional equipment such as imaging machines, monitors and implants but also software and technologies incorporating artificial intelligence.

The resolution therefore calls for stronger regulatory systems, including appropriate oversight of software and AI used as medical devices. WHO will support countries through regulatory benchmarking and institutional development.

This is particularly relevant for countries such as India, where the medical-device sector is expanding rapidly and digital technologies are becoming increasingly embedded in diagnosis and treatment.

The emphasis, however, is not on regulation alone. Countries are also being encouraged to use health technology assessment and proportionate evidence reviews when deciding which technologies should enter public health benefit packages and receive public investment.

One of the more important aspects of the resolution is its approach to procurement. The cheapest equipment may not always be the least expensive option for a health system.

Member States are being encouraged to consider the total cost of ownership — installation, consumables, warranties, maintenance, spare parts, training, interoperability, cybersecurity, environmental considerations and continuity of supply.

This is particularly important in resource-constrained settings, where purchasing a sophisticated machine without planning for its subsequent costs can leave health facilities with expensive equipment that cannot be used.

The resolution therefore seeks performance-based procurement rather than an approach driven primarily by the initial purchase price.

The real test of the initiative, however, will be outside major cities, said the experts. WHO has specifically stressed access at primary and other appropriate levels of care, including rural, remote, island and underserved communities.

The South-East Asian countries will also seek greater cooperation through the South-East Asia Regulatory Network (SEARN), including regulatory reliance, work-sharing, safety-information exchange, common technical approaches and training.

Regional Centres of Regulatory Excellence for medical devices and IVDs are also envisaged, alongside stronger capacity in biomedical engineering and health technology management.

Countries could additionally collaborate voluntarily on pooled procurement, forecasting, strategic reserves, local and regional production and technology transfer — particularly important during health emergencies when global supply chains can become vulnerable.

The move builds on work already under way in the region on National Essential Diagnostics Lists (NEDLs), essential medical-device lists and assistive-product lists.

The South-East Asia Region currently has the highest number of countries with NEDLs among WHO regions. India was the first country in the world to develop an NEDL, while Nepal was the third. Thailand was the first ASEAN country to do so, followed by Timor-Leste. Myanmar and the Maldives are now working on their own lists.